# FDA recall D-0444-2024

> **AvKARE** · Class I · drug recall initiated 2024-03-28.

## Product

Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.

## Reason for recall

Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0444-2024
- **Recalling firm:** AvKARE
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-03-28
- **Report date:** 2024-04-24
- **Termination date:** 2024-08-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pulaski, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0444-2024

## Citation

> AI Analytics. FDA recall D-0444-2024. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/D-0444-2024. Source: US FDA. Licensed CC0.

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